NDC 70121-1037

Argatroban

Argatroban

Argatroban is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Amneal Biosciences Llc. The primary component is Argatroban.

Product ID70121-1037_0d38a4b8-5c5d-45b1-80ea-c5dc31faf5fc
NDC70121-1037
Product TypeHuman Prescription Drug
Proprietary NameArgatroban
Generic NameArgatroban
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-01-26
Marketing CategoryANDA / ANDA
Application NumberANDA206698
Labeler NameAmneal Biosciences LLC
Substance NameARGATROBAN
Active Ingredient Strength100 mg/mL
Pharm ClassesAnti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70121-1037-1

1 VIAL, GLASS in 1 CARTON (70121-1037-1) > 2.5 mL in 1 VIAL, GLASS
Marketing Start Date2018-01-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70121-1037-1 [70121103701]

Argatroban INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206698
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-01-26

Drug Details

Active Ingredients

IngredientStrength
ARGATROBAN100 mg/mL

OpenFDA Data

SPL SET ID:dedef330-555a-46b7-b1d6-0838b4cd9651
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308351
  • PHarm Class EPC
  • Direct Thrombin Inhibitor [EPC]
  • Anti-coagulant [EPC]
  • UPC Code
  • 0370121103714
  • NUI Code
  • N0000175518
  • N0000009963
  • N0000175980
  • Pharmacological Class

    • Anti-coagulant [EPC]
    • Direct Thrombin Inhibitor [EPC]
    • Thrombin Inhibitors [MoA]

    NDC Crossover Matching brand name "Argatroban" or generic name "Argatroban"

    NDCBrand NameGeneric Name
    0078-0930ARGATROBANargatroban
    0143-9288ArgatrobanArgatroban
    0143-9377ArgatrobanArgatroban
    0143-9559ArgatrobanArgatroban
    0143-9674ArgatrobanArgatroban
    0409-1140ArgatrobanArgatroban
    0781-3285ArgatrobanArgatroban
    0781-3314ArgatrobanArgatroban
    0781-9314ArgatrobanArgatroban
    16729-430ARGATROBANArgatroban
    25021-414ArgatrobanArgatroban
    42023-182ArgatrobanArgatroban
    42367-202ArgatrobanArgatroban
    42367-203ArgatrobanArgatroban
    55150-241ArgatrobanArgatroban
    63323-526ArgatrobanArgatroban
    68083-141ArgatrobanArgatroban
    70121-1037ArgatrobanArgatroban
    67457-212ArgatrobanArgatroban
    65145-126ARGATROBANARGATROBAN

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